Advanced and/or metastatic renal cell carcinoma MedDRA version: 20.0 Level: HLT Classification code 10068208 Term: Renal neoplasms malignant System Organ Class: 100000004864
Conditions
Interventions
Trade Name: Votrient
Product Name: Votrient
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: PAZOPANIB HYDROCHLORIDE
CAS Number: 635702-64-6
Concentration unit: mg milligram(s)
Concentrati
Sponsors
Novartis Pharma AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Patient is = 18 years old at the time of informed consent. •Patient has histologically confirmed locally recurrent or metastatic predominantly clear cell renal cell carcinoma. •Patient must have measurable disease based on RECIST 1.1 criteria •Patient must have received prior systemic therapy with an immune checkpoint inhibitor (monotherapy or combination) as 1st or 2nd line RCC treatment. Note: patients with prior TKI treatment or mTOR inhibitor as monotherapy or in combination with immune checkpoint inhibitor are allowed; however, treatment with immune checkpoint inhibitor (monotherapy or in combination) must have been the last treatment prior to study entry. •Last dose of immune checkpoint inhibitor therapy must have been received 4 or more weeks before start of study treatment •Patient must have a Karnofsky performance status =70%. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 84 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 56
Exclusion criteria
Exclusion criteria: 1.Renal cell carcinoma without any clear (conventional) cell component 2. History or clinical evidence of central nervous system (CNS) metastases. • Note: Patients who have previously-treated CNS metastases (surgery ± radiotherapy, radiosurgery, or gamma knife) and meet all 3 of the following criteria are eligible: a. Asymptomatic and, b. Have had no evidence of active CNS metastases for =6 months prior to enrollment and, c. Have no requirement for steroids or enzyme-inducing anticonvulsants (EIAC). 3. Prior treatment with pazopanib. 4. Prior treatment with bevacizumab that was not given in combination with immune checkpoint inhibitor therapy. 5. Prior treatment with more than 2 lines of therapy (combination treatments are considered 1 line of therapy) 6. Patient has not recovered from toxicity from prior immune checkpoint inhibitor therapy. Recovery is defined as = CTCAE Grade 1, except for liver function test (LFT) levels which must be <Grade 1. 7. Patients receiving prohibited concomitant medications that cannot be discontinued or replaced by safe alternative medication at least 5 half-lives of the concomitant medication or 7 days, whichever is longer, prior to the start of pazopanib treatment. 8.Administration of any investigational drug within 4 weeks prior to the first dose of study treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the progression free survival based on local investigator assessment using RECIST 1.1;Secondary Objective: •To assess overall response rate and clinical benefit rate based on local investigator assessment •To assess overall survival •To assess duration of response in patients with confirmed complete response (CR) or partial response (PR) •To evaluate safety and tolerability •To assess quality of life ;Primary end point(s): Progression free survival;Timepoint(s) of evaluation of this end point: After all patients have received a minimum of 6 cycles of study treatment or have discontinued study treatment early and at the end of study | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): -Overall Response Rate and Clinical Benefit Rate based on local investigator assessment as per RECIST 1.1 -Overall survival -Duration of Response in the subset of patients with confirmed CR / PR -Safety and tolerability -PRO assessed by EQ-5D and FKSI-DRS questionnaires;Timepoint(s) of evaluation of this end point: ORR, OS, DOR will be evaluated at the same time as the primary endpoint and at the end of study; however, some patients may not have reached these endpoints at the time of the primary endpoint evaluation so the secondary endpoint results at the end of the study should be considered more meaningful. | — |
Countries
Argentina, Austria, Canada, Chile, Czechia, Czech Republic, France, Germany, Hungary, Japan, Spain, United Kingdom, United States
Contacts
Public ContactMedizinischer Infoservice (MCC)
Novartis Pharma GmbH
Outcome results
None listed